510(k) · Cleared

Cleared

Radlite Tissue Retractor System

K022989510(k) TraditionalCleared Nov 25, 200277-day reviewClass II21 CFR 878.4580

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genzyme Biosurgery · FSW Light, Surgical, Endoscopic

Cleared on Nov 25, 2002 as substantially equivalent to K960400 (Snowden-Pencer, 1996) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1994.

Decided: Nov 25, 2002
Review: 77 days
Class: Class II
Product code: FSW
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K930667 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
1 generation backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
This deviceK022989 Radlite Tissue Retractor SystemGenzyme Biosurgery · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K930667	Reusable Laparoscopic Instruments	Snowden-Pencer	1994	15
−1	K960400	Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…	Snowden-Pencer	1996	—
0 (this device)	K022989	Radlite Tissue Retractor System	Genzyme Biosurgery	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	1	0

FIG. 1 — Lineage of K022989, 1994–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FSW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K960400	Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port… Summary page 1 …ine substantial equivalence for the Genzyme Tissue Retractor System, are the SaphLITE@ System marketed by Genzyme Biosurgery, Fall River, MA 02720 (K960400), and the ENDOPATH@ Ultra- Retractor marketed by Ethicon Endo-Surgery, Inc. (K973 139) 4. DEVICE DESCRIPTION: The Ge…	Snowden-Pencer	1996	—
*	K973139	Endopath Ultra-Retractor/ Endopath Vessel Dissector Summary page 1 …@ System marketed by Genzyme Biosurgery, Fall River, MA 02720 (K960400), and the ENDOPATH@ Ultra- Retractor marketed by Ethicon Endo-Surgery, Inc. (K973 139) 4. DEVICE DESCRIPTION: The Genzyme Tissue Retractor System s is a surgical instrument that provides a means to create and main…	Ethicon Endo-Surgery, Inc.	1997	—

Also cleared against K960400: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
1 of the 4 ancestors has a recall of any class.
3 other devices also cite its predicate K960400.

How does its category compare?

All FSW devices

FSW Light, Surgical, Endoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FSW

FDA has decided no FSW device since 2007.

Median 510(k) review, days · FSW

Too few FSW 510(k)s in any year since 2007 to give a median.

Recalls per year · FSW

No recall names FSW since 2007.

Adverse event reports per year · FSW

1in 2012

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code FSW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The RarUliteTM Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022989 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022989: Radlite Tissue Retractor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022989

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026